Location: Spain and Hungary
Functional Goal:
Responsible for the strategic and tactical operational planning and execution of R&D; sponsored clinical programs for all corporate sponsored programs for Phase I - Phase IV.

Main Tasks:

Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas.

Collaborate in a integral environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.

Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.

Lead (multiple) cross-functional teams and drive oversight of CRO’s and vendor management and has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers, and key business drivers to increase effectiveness.





Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.)

Responsible for inspection readiness.

Accountable for CAPAS related to clinical programs within the field of Clinical Operations.

Accountable and responsible for the financial planning, budget, accruals, forecasts contribution.

Preparing clinical program updates and/or contribution to them as needed.

Qualification profile:

Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background

At least 7 years’ experience in clinical research in industry, and at least 5 years in clinical trial management

Understanding GxP and global requirements

Strong project management skillsets

Excellent communication skills and ability to manage cross functional teams

Ability to deal with com

📌 Senior Manager Clinical Operations (Madrid)
🏢 Fresenius Se Kgaa
📍 Madrid